Skip to main content
OpenTrials
Completed

NCT Number: NCT00115167

A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Cancer Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion criteria

  • Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
  • Subjects who have other diagnoses not related to the cancer which can cause anemia
  • Known history of seizure disorder
  • Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
  • Subject of reproductive potential who is not using adequate contraceptive precautions
  • Concerns for subject's compliance with the protocol procedures

Treatment and study plan

Placebo

Drug

Q4W

darbepoetin alfa

Drug

Q4W

Primary outcomes

  1. Incidence of adverse events

    Time frame: throughout study

Secondary outcomes

  1. Confirmed antibody formation to investigational product

    Time frame: throughout study

  2. Deaths on study

    Time frame: on study

  3. Laboratory parameters

    Time frame: throughout study

  4. Vital signs (blood pressure)

    Time frame: throughout study

  5. Change in PRO scores

    Time frame: from baseline to end of treatment

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 22, 2005
Registry last updated
May 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.